A Phase I Trial of a Trivalent Vaccine with Escalating Doses of the Immunological Adjuvant OPT-821 Plus Oral ß-Glucan for High-Risk Neuroblastoma

Protocol

05-075

Full Title

Phase I/II Trial of a Bivalent Vaccine with the Immunological Adjuvant OPT-821,in Combination with Oral ß-glucan for High-Risk Neuroblastoma

Phase

I/II

Purpose

The purpose of this study is to find the highest dose of a vaccine adjuvant called OPT-821 that can be given as part of a vaccine designed to treat neuroblastoma. The vaccine in this study targets three markers on neuroblastoma cells. The aim of the vaccine is to trigger a response of the immune system against neuroblastoma by causing the patient’s body to make antibodies against these markers which would, in turn, cause white blood cells to find and attack the cancer cells.

Other substances called adjuvants are added to cancer vaccines to boost the immune response against cancer cells. OPT-821 and KLH are the two adjuvants in this vaccine. OPT-821 is another version of adjuvant QS-21 which has been used in the past but is no longer available. Investigators want to see what dose of OPT-821 can be safely given in children. Patients will also take by mouth ß-glucan, a yeast sugar that can help white blood cells kill cancer cells.